FDA Approval: First New Long-Acting Insulins in 10 Years

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

There have been several new insulin products approved over the past year, including Toujeo, Humalog U-200, Afrezza—and now Tresiba and Ryzodeg.

The other recent insulin approvals are what I like to call spin-off insulin products. For example, Toujeo has the same type of insulin as Lantus (insulin glargine), but is more concentrated. Humalog U-200 is the same exact product as Humalog U-100 (insulin lispro), but once again, more concentrated. Afrezza (insulin human) is the same as regular insulin but in a new inhaled form.

Tresiba and Ryzodeg, on the other hand, contain a new type of insulin—insulin degludec.

Tresiba is a long-acting insulin while Ryzodeg is mixed containing a combination of both long-acting (insulin degludec) and rapid-acting insulin (insulin aspart).

When were these new insulins approved?
Tresiba and Ryzodeg were both approved by the FDA on September 25, 2015.

How is Tresiba usually taken?

Dosing for Tresiba will be different for every person, but it’s typically injected subcutaneously once daily at any time of the day.

For more information take a look at the manufacturer website here.

How is Ryzodeg usually taken?

Dosing for Ryzodeg will also be different for each person, but it will usually be injected subcutaneously once or twice daily with any main meal. Ryzodeg doesn’t have an official website yet, but look for more information to come.

What dosage form(s) and strength(s) will Tresiba and Ryzodeg be available in?
Tresiba will be available as a FlexTouch disposable prefilled pen in two strengths: U-100 (100 units/mL) in 5-pen packages, and U-200 (200 units/mL) in 5-pen packages.

Ryzodeg will also be available as a FlexTouch pen, but only in the U-100 (100 units/mL) strength, and only in 5-pen packages.

What are the common side effects of Tresiba and Ryzodeg?

Some common side effects of both Tresiba and Ryzodeg include injection site reactions, skin thickening or pits at injection sites, itching, rash, swelling of hands or feet, and weight gain.

Is there anything unique about Tresiba or Ryzodeg?

Yes! Insulin degludec (Tresiba, and one of the active ingredients in Ryzodeg) is the first new long-acting insulin to be approved by the FDA in 10 years.

Are there any benefits of using Tresiba compared to other long-acting insulin products?
Tresiba has a more flexible dosing schedule. According to the manufacturer Tresiba can last up to 42 hours which allows you to use it at any time of day.

The Tresiba FlexTouch disposable pens also last up to 56 days (8 weeks) once in-use at room temperature—which is longer than both long-acting insulin products Lantus and Levemir.

Drugs featured in this story

Filed under